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Inova Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories11
Latest FDA decision2026-02-06
TypeNumberDevice NameCodeDateActions
510(k) K243979 Aptiva APS IgA ReagentMSV2026-02-06 View
510(k) K223093 Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID2024-12-17 View
510(k) K213403 Aptiva CTD Essential ReagentLLL2023-09-29 View
510(k) K200230 Aptiva Celiac Disease IgG ReagentMVM2021-08-26 View
510(k) K193604 Aptiva Celiac Disease IgA ReagentMVM2021-06-16 View
510(k) K192916 NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL2020-12-11 View
510(k) K190088 QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR2019-04-17 View
510(k) K180971 QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO2018-10-16 View
510(k) K180975 QUANTA Flash HMGCR ReagentsLLL2018-06-25 View
510(k) K170993 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction BufferNXO2017-12-22 View
510(k) K163538 QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsNBS2017-09-06 View
510(k) K163525 QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsDBM2017-09-05 View
510(k) K161258 NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB2017-02-03 View
510(k) K152635 QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL2016-06-01 View
510(k) K152013 QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW2016-04-11 View
510(k) K151429 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL2016-02-12 View
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